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Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

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ClinicalTrials.gov Identifier: NCT00898222
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : November 4, 2014
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Intervention Drug: aspirin
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin
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Low dose daily aspirin in healthy volunteers for two weeks

aspirin : 81 mg orally daily for two weeks

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Aspirin
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Low dose daily aspirin in healthy volunteers for two weeks

aspirin : 81 mg orally daily for two weeks

Overall Number of Baseline Participants 4
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
26  (2.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Change in Exhaled Inflammatory Mediator Levels
Hide Description Descriptive statistics
Time Frame baseline and 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin
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Low dose daily aspirin in healthy volunteers for two weeks

aspirin : 81 mg orally daily for two weeks

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: pg/mL
1.42
(0.23 to 1.98)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin
Hide Arm/Group Description

Low dose daily aspirin in healthy volunteers for two weeks

aspirin : 81 mg orally daily for two weeks

All-Cause Mortality
Aspirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin
Affected / at Risk (%)
Total   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Shamsah Kazani
Organization: Brigham and Women's Hospital
Phone: 617-732-8201
EMail: skazani@partners.org
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Responsible Party: Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00898222     History of Changes
Other Study ID Numbers: ARC ASA Normal
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: July 16, 2014
Results First Posted: November 4, 2014
Last Update Posted: September 25, 2015